Senior Global CAPA Engineer
About The Position
The Sr. Global CAPA Engineer serves as a subject matter expert for the Global Corrective and Preventive Action (CAPA) Program, providing technical leadership, facilitation, and guidance to ensure effective investigation, root cause analysis, corrective action implementation, and effectiveness verification across CooperSurgical. This role partners with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, Supply Chain, and other functional teams to support the timely execution of CAPAs, strengthen problem-solving capabilities, and drive continuous improvement across the organization. The Sr. Global CAPA Engineer is responsible for supporting the execution and effectiveness of CooperSurgical's Global CAPA Program. This role provides expert guidance to CAPA owners on investigation techniques, root cause analysis, risk evaluation, corrective action development, effectiveness verification, and documentation requirements. The Sr. Global CAPA Engineer facilitates complex and high-risk CAPAs, performs quality reviews of CAPA records, analyzes CAPA trends, and identifies opportunities to improve quality system performance. Working closely with cross-functional stakeholders, this role helps ensure CAPAs are executed consistently, effectively, and in compliance with applicable regulatory requirements and company procedures.
Requirements
- Subject matter expert for the Global Corrective and Preventive Action (CAPA) Program.
- Technical leadership, facilitation, and guidance for effective investigation, root cause analysis, corrective action implementation, and effectiveness verification.
- Partnership with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, Supply Chain, and other functional teams to support timely CAPA execution.
- Strengthening problem-solving capabilities and driving continuous improvement across the organization.
- Expert guidance to CAPA owners on investigation techniques, root cause analysis, risk evaluation, corrective action development, effectiveness verification, and documentation requirements.
- Facilitation of complex and high-risk CAPAs.
- Quality reviews of CAPA records.
- Analysis of CAPA trends.
- Identification of opportunities to improve quality system performance.
- Ensuring CAPAs are executed consistently, effectively, and in compliance with applicable regulatory requirements and company procedures.
Responsibilities
- Serve as a subject matter expert for the Global Corrective and Preventive Action (CAPA) Program.
- Provide technical leadership, facilitation, and guidance for effective investigation, root cause analysis, corrective action implementation, and effectiveness verification.
- Partner with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, Supply Chain, and other functional teams to support timely CAPA execution.
- Strengthen problem-solving capabilities and drive continuous improvement across the organization.
- Provide expert guidance to CAPA owners on investigation techniques, root cause analysis, risk evaluation, corrective action development, effectiveness verification, and documentation requirements.
- Facilitate complex and high-risk CAPAs.
- Perform quality reviews of CAPA records.
- Analyze CAPA trends.
- Identify opportunities to improve quality system performance.
- Ensure CAPAs are executed consistently, effectively, and in compliance with applicable regulatory requirements and company procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
